Ethical conduct is the backbone of all health-related research. Hospitals and academic institutions establish a Research and Ethical Committee to ensure that research involving human participants is scientifically sound, ethically justified, and conducted with complete respect for human dignity and safety. This committee acts as a regulatory and advisory body, protecting the rights, privacy, and well-being of research participants while promoting high-quality scientific research.
What Is a Research and Ethical Committee?
A Research and Ethical Committee (REC), also referred to as an Institutional Ethics Committee (IEC), is an independent body responsible for reviewing, approving, and monitoring biomedical research involving human subjects. It ensures that all proposals comply with national and international ethical standards such as the ICMR guidelines, Declaration of Helsinki, and GCP (Good Clinical Practice) norms.
Objectives of the Research and Ethical Committee
- Safeguard the dignity, rights, and safety of research participants.
- Evaluate research proposals for ethical soundness and scientific validity.
- Ensure informed consent procedures are properly followed.
- Monitor ongoing research to detect deviations or violations.
- Promote responsible conduct of research within the institution.
- Ensure transparency and accountability in research activities.
Need for a Research and Ethical Committee
Research involving human subjects carries inherent risks. There may be concerns related to privacy, informed consent, compensation, and possible harm. Ethical oversight protects participants from exploitation, ensures justice, and maintains scientific integrity. Without such a committee, research may violate human rights, leading to legal, ethical, and professional consequences.
Composition of the Ethical Committee
An effective REC must be multidisciplinary and independent. A typical committee consists of:
- Chairperson – Not affiliated with the institution to ensure impartiality.
- Member Secretary – Often a senior faculty member who coordinates committee activities.
- Basic Medical Scientist – Expert in anatomy, physiology, or pharmacology.
- Clinician – Senior physician with clinical experience.
- Legal Expert – Knowledgeable in medical and research regulations.
- Social Scientist – Sociologist, psychologist, or social worker.
- Lay Person – Represents community interests.
- Pharmacologist/Pharmacist – Provides drug-related and safety insights.
- Additional Experts – Bioethicists, statisticians, or microbiologists when required.
Functions of the Research and Ethical Committee
1. Scientific and Ethical Review of Proposals
The REC evaluates all research protocols before approval. Key aspects reviewed include:
- Scientific design and methodology
- Risk–benefit assessment
- Selection criteria for study participants
- Compensation and insurance provisions
- Safety monitoring plans
2. Ensuring Informed Consent
Informed consent is a mandatory requirement for ethical research. The REC ensures that:
- Consent forms are clear, simple, and non-coercive.
- Participants are fully aware of risks, benefits, and alternatives.
- Special protections exist for vulnerable groups (children, elderly, mentally ill).
3. Monitoring Approved Research
Ethical oversight continues beyond approval:
- Periodic review of research progress reports.
- Inspection of research sites when necessary.
- Ensuring that deviations or protocol violations are corrected immediately.
- Monitoring safety reports and adverse events.
4. Protection of Vulnerable Populations
Extra precautions are taken when research involves:
- Children
- Pregnant women
- Economically or socially disadvantaged individuals
- Mentally disabled persons
- Terminally ill patients
5. Ensuring Confidentiality and Privacy
REC ensures that participant information is kept confidential and stored securely. Identifiable data must not be disclosed without permission.
6. Ethical Guidance and Training
The committee also organizes workshops, seminars, and training sessions on:
- Research ethics
- Good Clinical Practice (GCP)
- Ethical writing and publication practices
- Regulatory updates
Responsibilities of the Research and Ethical Committee
- Review all research proposals involving human participants.
- Approve or reject proposals based on ethical and scientific merit.
- Ensure equitable selection of study participants.
- Monitor ongoing research to ensure compliance with approved protocols.
- Review amendments made to existing research proposals.
- Report unethical practices to institutional authorities.
- Maintain detailed records of meetings and approvals.
Review Types
The committee follows one of the three review pathways depending on risk level:
- Exempt Review: For minimal-risk studies such as surveys or educational research.
- Expedited Review: For low-risk studies involving limited procedures.
- Full Committee Review: Required for high-risk or vulnerable-group studies.
Ethical Principles Followed by the REC
- Autonomy: Respecting participants’ right to make informed decisions.
- Beneficence: Ensuring research benefits outweigh risks.
- Non-maleficence: Preventing harm to participants.
- Justice: Fair selection and equal treatment of subjects.
Detailed Notes:
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